Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Strengths and Difficulties Questionnaire
研究概览
简要总结
Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life.
详细描述
The aim of this clinical trial is to conduct an evaluation of whether children who participate in the Kids' Empowerment Program (KEP) have fewer symptoms of depression and anxiety after 12 weeks relative to those in the comparison group.
Further, the investigator seeks to identify for whom the program is most helpful and elements of the program that contribute to success. The experimental condition consists of both those who experience the KEP in-person in their classroom (n = 60) and 60 in the comparison condition. Standardized measures assess children's mental health, coping, resilience, and emotion regulation before and after 12 weeks. Those in the comparison group receive the KEP program in their classroom after the second interview. Children are interviewed at school and parents complete an online survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
To minimize the possibility of a breach in confidentiality, each child's and parent's information is protected with a code number that will be associated with all of their study materials instead of their name. All identifying information is stored in a separate locked cabinet in the office of Dr. Graham-Bermann. All other study materials (without names) will be kept in a locked cabinet in the research laboratory of Dr. Graham-Bermann to maintain privacy.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child age 6 to 12 years
- •Parent consents to participate interviews and the program
- •Parent agrees to two assessments
排除标准
- •Child age younger than 6 and older than 12
- •Child with significant developmental or cognitive delays prohibiting program participation
研究组 & 干预措施
The KEP Group
Children in the KEP group will be interviewed before and after participation in the 12 weeks Kids' Empowerment Program in their classroom. Their parent will complete an online assessment via survey software before their child begins the program and again after 12 weeks.
干预措施: The Kids' Empowerment Program (Behavioral)
The Comparison Group
Children in the comparison group will be interviewed once and again 12 weeks later. Their parent will complete an online assessment once and again 12 weeks later. Children in the Comparison group will then participate in the Kids' Empowerment Program in their classroom.
结局指标
主要结局
Strengths and Difficulties Questionnaire
时间窗: Pre-intervention and 12 weeks later
Parent reported and child self-rated aggression, peer problems, and pro social skills - 15 items (5 items each scale). Scoring ranges from 0 to 2. Minimum score for each scale is 0 and maximum score if 10. Higher scores indicate greater aggression, greater peer problems, and greater prosocial behavior.
Revised Children's Anxiety and Depression Scale
时间窗: Pre-intervention and 12 weeks later
Parent reported and child self-rated symptoms of child's anxiety and depression - 25 items, scored 0 to 3, with minimum score of 0 and highest score of 75. Higher scores indicate greater anxiety and depression.
次要结局
- Cognitive Emotion Regulation Questionnaire(Pre-intervention and 12 weeks later)
研究者
Sandra A Graham-Bermann
Professor of Psychology, College of Literature, Science, and the Arts and Professor of Psychiatry, Medical School
University of Michigan